A Study of RG7625 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295332
• Other study ID #: WP29542
• Secondary ID: 2014-003538-23
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2014
• Last updated: November 1, 2016
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.

The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy male and female participants, 18 to 60 years of age, inclusive

• A body mass index between 18 to 30 kg/m2 inclusive

• Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

• Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders

• Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit

• Any significant allergic reaction to drugs

• Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study

• Women who are pregnant or lactating or of childbearing potential

• Clinically significant abnormal ECG or other risk factors for QT prolongation

• Use of prescribed or over the counter medication

• Inability or unwillingness to comply with study requirements

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Matching oral placebo capsules to RG7625, according to treatment schedule
• RG7625
oral administration, capsules, single ascending dose according to treatment schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs		Approximately 22 weeks	No
Secondary	Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR]		22 weeks	No
Secondary	Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure		22 weeks	No